First ECMO System Integrated with Non-Invasive Blood Sensor Technology to Treat Heart and Lung Failure

Extracorporeal membrane oxygenation (ECMO) is an advanced form of life support used to treat patients with life-threatening heart and lung failure. ECMO systems are designed to directly oxygenate and remove carbon dioxide from a patient's blood, replacing the entire lung function by circulating all of the patient's blood (5-7 liters) every minute. As a last resort procedure, it requires the patient to be confined to ICUs and is associated with a high level of medical risks. Now, for the first time, a new generation ECMO system integrated with non-invasive blood sensor technology offers potential advantages that may improve usability and patient care.

Inspira Technologies (Ra'anana, Israel) is developing the Liby System, a new generation ECMO system that includes several new features and capabilities as well as a new approach to medical device designs, including a large touchscreen and novel colorful graphical representation that increases the visibility, scope and functionality of data displayed to the medical staff. With its small footprint and lightweight characteristics, the Liby system is being designed with a rapid style aerospace-grade aluminum structure to be both lightweight and highly durable, and will be equipped with long battery life, a contributing factor to making the Liby system suitable for patient mobility within hospitals and for transportation of patients to hospitals in ambulances.

The Liby system is also expected to be the first system designed for integration with the company's recently revealed non-invasive HYLA blood sensor technology. The HYLA non-invasive blood sensor is attached to the outer walls of a tube that has blood flowing through it and is being designed as a new platform based on key technologies being developed for Inspira’s ART system, designed to reduce the need for invasive mechanical ventilation. The HYLA blood sensor is designed to minimize the need for invasive medical procedures with the intention of reducing risks, complications and costs. The addition of the HYLA to patients treated with the Liby system, would potentially allow for the real-time and continuous monitoring of patient condition to alert physicians of immediate signs of changes in a patient's clinical condition. The Liby system is expected to be submitted to the FDA for approval during the first half of 2023. Subject to FDA approval, the Liby system's expected regulatory pathway is intended to be designated as a Class II 510 (K), meaning it may not require human trials.

"The Liby system is intended to target one of three market segments within Inspira Technologies product scope,” said Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies. "The Liby system is expected to introduce the next generation of ECMO within Intensive Care Units (ICUs), due to its practical advantages, designed to improve durability, patient mobility both within the hospital or via ambulance, and ease of use. I believe that these are important advantages for medical teams within over-crowded ICUs, targeting to improve patient outcomes."

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